Efficacy and Safety of Raltitrexed-based Transarterial Ch... | NCT01959061

Studies
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases

NCT01959061

Sponsor

Nanjing Chia-tai Tianqing Pharmaceutical

Status

Unknown status

Last Update Posted

Mar 13, 2017Actual

Enrollment

320Estimated

Phase

Phase 4

Conditions

Colorectal Cancer Metastatic

Interventions

Raltitrexed
Oxaliplatin
lipiodol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Sep 18, 2013

First Submission Date that Met QC Criteria

Oct 7, 2013

First Posted Date

Oct 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2017

Last Update Posted Date

Mar 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

Detailed Description

evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raltitrexed and Oxaliplatin	Experimental	Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.	Drug: Raltitrexed Drug: Oxaliplatin Drug: lipiodol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raltitrexed	Drug	4mg, every 4 weeks,transhepatic arterial infusion	Raltitrexed and Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survivial	From date of randomization until date of first documented PD, date of death	8 months after last patient randomized

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma
Disease limited to the liver Unresectable disease by surgery or other local therapies
Age >18 years
ECOG performance status 0-2,Child pugh A or B
Expected survival ≥ 3 months
Adequate hematological, hepatic, and renal function

Exclusion Criteria:

Pregnant or lactating women
Patients with severe organ dysfunction or failure
With severe cardiovascular disease, or mental
Extraliver metastases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianhua Wang	Contact	021-64041990		wang.jianhua@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Jianhua Wang	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital Fudan University	Recruiting	Shanghai	Shanghai Municipality	2000032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C068874	raltitrexed
D000077150	Oxaliplatin
D004998	Ethiodized Oil

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D007459	Iodized Oil
D010938	Plant Oils

Browse Leaves

Not provided

Browse Branches

Not provided